REG - Allergy Therapeutics - Interim Results for six months ended 31 Dec 2024
31/03/2025 07:15
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RNS Number : 8342C Allergy Therapeutics PLC 31 March 2025
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company" or the "Group")
Interim Results for the six months ended 31 December 2024
31 March 2025: Allergy Therapeutics plc (AIM: AGY), the fully integrated
commercial biotechnology company specialising in allergy vaccines, announces
its unaudited interim results for the six months ended 31 December 2024.
Highlights
Financial
- Operating profit of £1.9 million before R&D, exceptional and
fundraising costs (FY2024 H1: £0.5 million operating loss pre-R&D and
exceptional costs).
- Cash position of £21.7 million at 31 December 2024 (30 June 2024:
£12.9 million).
- Financial turnaround progressing with H1 revenues of £34.0 million
(FY2024 H1: £33.6 million), 4% growth on a constant currency basis (FY2024
H2: 2% growth).
- Second consecutive period of half year growth with improved
operating margin.
- Continued focus on cost control, with total administrative expenses
reduced by 9.7% against comparative period.
Operational
- Increase of 5% in volume of units sold reflecting a recovery in
manufacturing capacity and improved ability to meet market demand.
- Submission of Marketing Authorisation Application for Grass MATA MPL
in November 2024.
- First patient treated in the G308 Phase III trial to evaluate
long-term efficacy and safety of Grass MATA MPL in paediatric patients.
- Positive interim analysis data from the Phase I/IIa VLP Peanut
PROTECT Trial showing up to 48% reduction in wheal size after skin-prick
testing compared to 8% in placebo, indicating significant potential efficacy
of the product.
Manuel Llobet, CEO at Allergy Therapeutics, commented: "We enter 2025 with
clear positive momentum across all aspects of our business. Our return to
first-half growth and strengthened financial foundation give us renewed
confidence to advance our strategic priorities. The submission of our
Marketing Authorisation Application for Grass MATA MPL in Germany and the
start of our paediatric G308 trial mark significant progress in our grass
allergy programme. Simultaneously, the encouraging interim data from our VLP
Peanut programme demonstrating meaningful reductions in skin sensitivity
reinforce the transformational potential of this innovative vaccine candidate.
With these developments, we are well positioned to deliver on our commitment
to transform patient care in allergy while building sustainable value."
Financial Review
Revenue for the six months ended 31 December 2024 was £34.0 million (FY2024
H1: £33.6 million) representing 1% growth on a reported basis, or more than
4% on a constant* currency basis. Revenue has now grown for two consecutive
half year periods, when compared to the equivalent periods in the prior
financial year, demonstrating that the Group's financial recovery continues.
Further, the volume of units sold increased by 5%, indicating a recovery in
manufacturing output, with the growth primarily driven by a rebuild of the
diagnostic portfolio.
Cost of sales increased slightly to £13.2 million (FY2024 H1: £13.1 million)
in line with the higher sales volumes and maintaining broadly the same gross
margin of 61%.
Sales, marketing and distribution costs were lower than the prior period at
£9.3 million (FY2024 H1: £10.2 million) mainly as a result of streamlined
marketing and promotional activity. Administrative expenses reduced to £10.4
million (FY2024 H1: £11.6 million) as a result of continued successful cost
control initiatives.
The Group made an operating profit pre-R&D, exceptional and fundraising
costs of £1.9 million (FY2024 H1: £0.5 million operating loss pre-R&D
and exceptional costs).
Research and development costs reduced to £7.6 million (FY2024 H1: £11.4
million) mainly due to the prior period including the peak activity of the
Group's pivotal G306 Phase III trial of Grass MATA MPL which successfully met
its primary endpoint during H1 of FY2024.
There were no exceptional costs in this or the prior period, however there was
a total fundraising charge of £2.9 million (FY2024 H1: £nil), this includes
£0.4 million of transaction costs associated with the warrants issued to
Hayfin Healthcare Opportunities ("Hayfin"), a £2.9 million accounting loss
due to the revaluation of the Hayfin warrants to fair value at the reporting
date, partially offset by a £0.4 million accounting gain on modification of
the Loan Facility provided by SkyGem Acquisition Limited and Southern Fox
Investments Limited (together the "Shareholder Lenders").
The operating loss was £8.6 million (FY2024 H1: £11.9 million), and the loss
before tax was £11.4 million (FY2024 H1: £14.9 million). The finance expense
for the period was £3.0 million (FY2024 H1: £3.2 million) mainly comprising
interest expenses on the shareholder loan and Hayfin facility. Tax was a
credit of £0.3 million (FY2024 H1: £0.7 million tax charge) relating to
movements in the Group's liability for uncertain tax positions and tax payable
by the overseas subsidiaries.
At 31 December 2024, the Group had cash of £21.7 million (30 June 2024:
£12.9 million) and debt of £37.5 million (30 June 2024: £23.1 million).
The operating cash outflow was £7.7 million (FY2024 H1: £10.8 million) an
improvement of 29% reflecting the improving operational performance. The
investing outflow was £1.4 million (FY2024 H1: £1.8 million), offset by an
inflow of £17.8 million (FY2024 H1: £11.2 million) from the net proceeds of
financing activities.
On 15 October 2024 the Group strengthened its cash position (and increased its
debt) with a new £40m facility from Hayfin. As previously announced the
Hayfin Facility comprises a £20 million committed five-year term loan and
£20 million uncommitted incremental facility. As part of these financing
arrangements, the Company has also issued to Hayfin 131,603,616 warrants to
subscribe for new ordinary shares, representing approximately 2.7% of the
issued share capital of the Company, with a nominal exercise price of 0.1
pence per warrant and exercisable for a period of ten years from the date of
issue. The Hayfin £20 million loan is subject to an upfront arrangement fee
and has a variable interest rate based on SONIA plus 9.5% per annum with
interest payable based on Company selected interest periods.
Also on 15 October 2024, the Group secured additional support from its
Shareholder Lenders, through an amendment to the Loan Facility. The total
facility was increased from £40 million to £50 million and its term extended
to October 2030. The Shareholder Facility has been amended ("the Amended
Shareholder Facility") to be unsecured and rank behind the Hayfin Facility. In
addition, interest under the Amended Shareholder Facility will no longer be
paid and instead interest will be rolled up into capital.
As at 31 December 2024 there was an undrawn but uncommitted balance of £27.5
million remaining on the Amended Shareholder Facility. With the £20 million
uncommitted Hayfin funding, the Group has access to a total £47.5 million of
uncommitted facilities to continue to drive the business forward. The Group
expects that additional funding will be required during Q4 FY2025 onwards for
trading, working capital, capital expenditure and continuing R&D
programmes.
The Directors have applied the going concern principle in preparing the
interim results for the six months ended 31 December 2024.
Clinical Update
Grass MATA MPL Programme
Grass MATA MPL, the Group's short-course subcutaneous allergen-specific
immunotherapy (SCIT) candidate for allergic rhinoconjunctivitis due to grass
pollen, achieved a key milestone in its clinical development with the
submission of its Marketing Authorisation Application to the Paul Ehrlich
Institut in Germany in November 2024.
This submission follows the successful completion of the pivotal Phase III
G306 trial in adults, which demonstrated a highly statistically significant
reduction in Combined Symptom & Medication Score of -20.3% (p≤0.0002)
compared to placebo over the peak pollen season.
Building on this, in November 2024, the Group initiated G308, an
industry-first long-term subcutaneous allergen-specific immunotherapy Phase
III trial in paediatric subjects with grass induced allergic rhinitis.
VLP Peanut Programme
The clinical development of VLP Peanut, the Group's innovative short-course
peanut allergy vaccine candidate administered via subcutaneous injection,
continues to progress through the Phase I/IIa PROTECT trial. This trial is
evaluating maximum safe and tolerated doses while assessing biomarker efficacy
in peanut allergic patients.
Interim analysis of the first two cohorts of peanut allergic patients has
shown promising results. Treatment with VLP Peanut resulted in a meaningful
dose-dependent reduction in skin sensitivity to peanut allergen, with up to
48% reduction in wheal size after skin-prick test compared to an 8% reduction
in placebo-treated patients. Further, a comparison of the biomarker profile
between treatment and placebo points to VLP Peanut driving a reduction in
allergic response to the major peanut allergen, Ara h2.
These findings are supported by pre-clinical research published in the Journal
of Allergy and Clinical Immunology in collaboration with Imperial College
London, which demonstrated beneficial tolerogenic properties and reduced
allergenicity in cells from peanut-allergic individuals.
The hypo-allergic safety profile observed to date supports the potential of
the product as a transformative treatment option for peanut allergy sufferers.
Outlook
In the second half of the financial year, we expect further sales growth when
compared to H2 2024 and we expect overall sales for the full year to show
growth over the corresponding period ended 30 June 2024. The Group is
continuing with cost control initiatives but is undertaking selective
investments such as launch readiness for its new Grass MATA MPL product should
MAA approval be received during FY2026.
The Group plans to meet with the US Food and Drug Administration in the coming
months to present new data and discuss US specific registration requirements,
including the design of US specific studies which is a standard requirement to
expand the number of subjects treated with the new products.
The Group expects that additional funding will be required during Q4 FY2025
onwards and discussions are underway regarding the utilisation of the
uncommitted facilities referenced in the Financial Review.
*Constant currency uses prior year weighted average exchange rates to
translate current year foreign currency denominated revenue to give a
year-on-year comparison excluding the effects of foreign exchange movements.
This announcement contains inside information for the purposes of the UK
Market Abuse Regulations.
- ENDS -
For further information, please contact:
Allergy Therapeutics
Manuel Llobet, Chief Executive Officer
Shaun Furlong, Chief Financial Officer
+44 (0)1903 845 820
Cavendish Capital Markets Limited (Nominated Adviser and Broker)
Geoff Nash/Giles Balleny/Seamus Fricker/Rory Sale
Nigel Birks Sales
+44 (0)20 7220 0500
ICR Healthcare
Mary-Jane Elliott/David Daley/Davide Salvi
+44 (0)20 3709 5700
allergytherapeutics@icrhealthcare.com
(mailto:allergytherapeutics@icrhealthcare.com)
About Allergy Therapeutics
Allergy Therapeutics is an international commercial biotechnology company,
headquartered in the UK, focussed on the treatment and diagnosis of allergic
disorders, including aluminium free immunotherapy vaccines that have the
potential to cure disease. The Group sells proprietary and third-party
products from its subsidiaries in nine major European countries and via
distribution agreements in an additional ten countries. Its broad pipeline of
products in clinical development includes vaccines for grass, tree, house dust
mite and peanut. For more information, please see www.allergytherapeutics.com
(http://www.allergytherapeutics.com/) .
ALLERGY THERAPEUTICS PLC
Consolidated income statement
6 months to 6 months to 12 months to
31 Dec 2024 31 Dec 2023 30 Jun 2024
£'000 £'000 £'000
Unaudited Unaudited Audited
Revenue 34,030 33,572 55,199
Cost of sales (13,168) (13,052) (25,462)
Gross profit 20,862 20,520 29,737
Sales, marketing and distribution costs (9,307) (10,222) (19,591)
Administration expenses - other (10,365) (11,558) (22,790)
Total administrative expenses (19,672) (21,780) (42,381)
Other income 733 760 1,526
Operating profit/(loss) pre R&D, exceptional and fundraising costs 1,923 (500) (11,118)
Research and development costs (7,647) (11,386) (22,900)
Exceptional costs - restructuring - - (1,239)
Transaction fees on financial instruments held at fair value (362) - -
Revaluation of warrant liabilities held at fair value (2,956) - -
Gain on modification of shareholder loan 430 - -
Operating loss (8,612) (11,886) (35,257)
Finance income 213 159 285
Finance expense (2,963) (3,189) (4,194)
Loss before tax (11,362) (14,916) (39,166)
Income tax 277 (735) (1,050)
Loss for the period (11,085) (15,651) (40,216)
Loss per share
Basic (pence per share) (0.23)p (0.58)p (1.07)p
Diluted (pence per share) (0.23)p (0.58)p (1.07)p
Consolidated statement of comprehensive income
6 months to 6 months to 12 months to
31 Dec 2024 31 Dec 2023 30 Jun 2024
£'000 £'000 £'000
Unaudited Unaudited Audited
Loss for the period (11,085) (15,651) (40,216)
Items that will not be reclassified subsequently to profit or loss:
Remeasurement of retirement benefit obligations (288) (749) (617)
Remeasurement of investments - retirement benefit assets 85 324 549
Revaluation gains - land and buildings - - 281
Deferred tax movement - land and buildings - - (30)
Total other comprehensive loss (203) (425) 183
Items that may be reclassified subsequently to profit or loss:
Exchange differences on translation of foreign operations (291) 392 (86)
Total comprehensive loss (11,579) (15,684) (40,119)
ALLERGY THERAPEUTICS PLC
Consolidated statement of financial position
31 Dec 2024 31 Dec 2023 30 Jun 2024
£'000 £'000 £'000
Unaudited Unaudited Audited
Assets
Non-current assets
Property, plant and equipment - right-of use assets 6,602 8,210 7,457
Property, plant and equipment - other 16,713 15,182 16,288
Intangible assets - goodwill 3,300 3,364 3,317
Intangible assets - other 1,214 1,626 1,370
Investment - retirement benefit asset 2,976 5,346 2,913
Total non-current assets 30,805 33,728 31,345
Current assets
Inventories 11,874 11,893 12,744
Trade and other receivables 8,615 9,934 7,823
Cash and cash equivalents 21,676 13,522 12,915
Total current assets 42,165 35,349 33,482
Total assets 72,970 69,077 64,827
Liabilities
Current liabilities
Trade and other payables (14,233) (20,088) (15,940)
Borrowings (503) (635) (600)
Derivative financial instruments (8,541) - -
Provisions (1,702) (3,434) (2,489)
Lease liabilities (1,451) (1,115) (1,516)
Total current liabilities (26,430) (25,272) (20,545)
Net current assets 15,735 10,077 12,937
Non-current liabilities
Retirement benefit obligations (8,792) (8,685) (8,611)
Deferred taxation liability (369) (463) (382)
Provisions (1,964) (95) (2,708)
Lease liabilities (5,606) (7,152) (6.372)
Long term borrowings (36,959) (948) (22,500)
Total non-current liabilities (53,690) (17,343) (40,573)
Total liabilities (80,120) (42,615) (61,118)
Net (liabilities) / assets (7,150) 26,462 3,709
Equity
Capital and reserves
Issued share capital 4,776 4,776 4,776
Share premium 154,639 154,672 154,639
Merger reserve 40,128 40,128 40,128
Reserve - share based payments 306 - 408
Revaluation reserve 1,782 1,501 1,782
Reserve - warrants 2,541 412 1,719
Foreign exchange reserve (1,107) (338) (816)
Retained earnings / (deficit) (210,215) (174,689) (198,927)
Total equity (7,150) 26,462 3,709
ALLERGY THERAPEUTICS PLC
Consolidated statement of changes in equity
Issued share Capital Share premium Merger reserve Reserve - share based payment Foreign exchange reserve Retained earnings / (deficit) Total equity
Revaluation reserve Reserve -
warrants
£'000 £'000 £'000 £'000 £'000 £'000 £'000 £'000 £'000
At 31 December 2023 4,776 154,672 40,128 - 1,501 (338) (174,689) 26,462
412
- - - - - (478) - (478)
Exchange differences on translation of foreign operations
-
Valuation gains taken to equity (land and buildings) - net of deferred tax - - - - 281 - (30) 251
-
Remeasurement of net defined benefit liability - - - - - - 132 132
-
Remeasurement of investments - retirement benefit assets - - - - - - 225 225
-
Total other comprehensive income - - - - 281 (478) 327 130
-
Loss for the period after tax - - - - - - (24,565) (24,565)
-
Total comprehensive loss - - - - 281 (478) (24,238) (24,435)
-
Share based payments - - - 408 - - - 408
-
Share issue costs - (33) - - - - - (33)
-
Warrants issued - - - - - - - 1,307
1,307
At 30 June 2024 4,776 154,639 40,128 408 1,782 (816) (198,927) 3,709
1,719
- - - - - (291) - (291)
Exchange differences on translation of foreign operations
-
Remeasurement of net defined benefit liability - - - - - - (288) (288)
-
Remeasurement of investments - retirement benefit assets - - - - - - 85 85
-
Total other comprehensive loss - - - - - (291) (203) (494)
-
Loss for the period after tax - - - - - - (11,085) (11,085)
-
Total comprehensive loss - - - - - (291) (11,288) (11,579)
-
Share based payments - - - (102) - - - (102)
-
Warrants issued - - - - - - - 822
822
At 31 December 2024 4,776 154,639 40,128 306 1,782 (1,107) (210,215) (7,150)
2,541
ALLERGY THERAPEUTICS PLC
Consolidated cash flow statement
6 months to 6 months to 12 months to
31 Dec 2024 31 Dec 2023 30 Jun 2024
£'000 £'000 £'000
Unaudited Unaudited Audited
Cash flows from operating activities
Loss before tax (11,362) (14,916) (39,166)
Adjustments for:
Finance income (213) (159) (285)
Finance expense 2,963 3,189 4,194
Non-cash movements on defined benefit pension plan 56 (160) 121
Depreciation and amortisation 1,935 2,114 4,319
Net monetary value of above the line R&D tax credit (733) (760) (1,526)
Charge for share-based payments (102) 351 759
Payments for retirement benefit investments - - (19)
Movement in fair value of derivative financial instruments 2,956 (79) (79)
Non-cash (gains) / losses on loans and other liabilities (430) - -
(Increase) / decrease in trade and other receivables (1,597) (3,307) 144
Decrease / (increase) in inventories 739 (255) (1,239)
(Decrease) / increase in trade and other payables (1,906) 3,174 788
Net cash used by operations (7,694) (10,808) (31,989)
Income tax (paid) / received (10) 34 (149)
Net cash used by operating activities (7,704) (10,774) (32,138)
Cash flows from investing activities
Interest received 109 69 135
Payments for property plant and equipment (1,524) (1,865) (3,401)
Receipts from disposal of investment assets - - 2,067
Net cash used in investing activities (1,415) (1,796) (1,199)
Cash flows from financing activities
Proceeds from issue of equity shares - 39,731 2,417
Share issue expenses - - (1,062)
Proceeds of bank borrowings 663 - 514
Repayment of bank borrowings (306) (333) (647)
Interest paid on bank borrowings (34) (17) (86)
Repayment of principal on lease liabilities (769) (409) (1,734)
Interest paid on lease liabilities (135) (159) (295)
Proceeds from shareholder loan 5,000 14,075 36,575
Repayment of shareholder loan (5,000) (40,075) (2,135)
Interest paid on shareholder loan (818) (1,629) (2,116)
Proceeds from other borrowings 19,370 - -
Fees paid in relation to other borrowings (197) - -
Net cash generated in financing activities 17,774 11,184 31,431
Net increase / (decrease) in cash and cash equivalents 8,655 (1,386) (1,906)
Effects of exchange rates on cash and cash equivalents 106 63 (24)
Cash and cash equivalents at the start of the period 12,915 14,845 14,845
Cash and cash equivalents at the end of the period 21,676 13,522 12,915
1. Interim financial information
The unaudited consolidated interim financial information is for the six months
ended 31 December 2024. The financial information does not include all the
information required for full annual financial statements and should be read
in conjunction with the consolidated financial statements of the Group for the
year ended 30 June 2024, which were prepared under International Financial
Reporting Standards (IFRS) in issue as adopted by the UK and with those parts
of the Companies Act 2006 that are relevant to the Group preparing its
accounts in accordance with UK-adopted IFRS.
The interim financial information has not been audited nor has it been
reviewed under ISRE (UK) 2410 (Revised) of the Financial Reporting Council.
The financial information set out in this interim report does not constitute
statutory accounts as defined in Section 434 of the Companies Act 2006.
2. Basis of preparation
As permitted, this interim report has been prepared in accordance with the AIM
rules and not in accordance with IAS 34 "Interim Financial Reporting". The
accounting policies adopted in this report are consistent with those in the
annual financial statements for the year to 30 June 2024. There are no
accounting standards that have become effective in the current period that
would have a material impact upon the financial statements.
Going Concern
The unaudited consolidated interim financial information has been prepared on
a going concern basis after considering the Group's and the Company's current
cash position and reviewing budgets and cash flow forecasts for a period of at
least 12 months from the date of approval of these financial statements.
On 15 October 2024 the Group entered into a £40 million secured senior loan
facility (the "Hayfin Facility") with Hayfin Healthcare Opportunities LuxCo
S.a.r.l., a fund advised by Hayfin Capital Management LLP. The Hayfin Facility
consists of a committed £20 million five-year term loan which has been fully
drawn and an additional uncommitted £20 million incremental facility.
Furthermore, following discussions with the major shareholders, SkyGem
Acquisition and Southern Fox (together the "Shareholder Lenders"), the
existing loan facility of £40 million (the "Shareholder Facility"), details
of which were announced on 27 December 2023, was increased to £50 million and
its term extended to October 2030. To date, £22.5 million has been drawn (net
of repayments) and is outstanding under the Shareholder Facility, leaving an
undrawn but uncommitted balance of £27.5 million. The Shareholder Facility
has been amended ("the Amended Shareholder Facility") to be unsecured and rank
behind the Hayfin Facility. In addition, interest under the Shareholder
Facility will no longer be paid and instead interest will be rolled up into
capital.
The Group continues to require funding for the foreseeable future, in
particular to fund the ongoing R&D programme. With the £20 million
committed Hayfin funding and £47.5 million of uncommitted facilities, from
both Hayfin and the Shareholder Lenders, the Group has access to sufficient
funding.
The Directors have prepared cash flow forecasts for the period to 31 March
2026 based on the arrangements in place for funding with Hayfin and
representations provided by the Shareholder Lenders over the Group's ability
to access funding under the Amended Shareholder Facility. These forecasts show
that the Group has access to sufficient funds for the 12 month going concern
review period.
3. Loss per share
6 months to 6 months to 12 months to
31 Dec 2024 31 Dec 2023 30 Jun 2024
Unaudited Unaudited Audited
Loss after tax attributable to equity shareholders (£'000) (11,085) (15,651) (40,216)
Issued ordinary shares at start of the period ('000) 4,766,440 679,105 679,105
Ordinary shares issued in the period ('000) - 4,087,335 4,087,335
Issued ordinary shares at end of the period ('000) 4,766,440 4,766,440 4,766,440
Weighted average number of shares in issue for the period 4,766,440 2,720,224 3,743,332
Weighted average number of shares for diluted earnings 4,766,440 2,720,224 3,743,332
Basic earnings per ordinary share (pence) (0.23)p (0.58)p (1.07)p
Diluted earnings per ordinary share (pence) (0.23)p (0.58)p (1.07)p
The diluted loss per share does not differ from the basic loss per share as
the exercise of share options would have the effect of reducing the loss per
share and is therefore not dilutive under the terms of IAS 33.
4. Events after the balance sheet date
There were no disclosable events after the balance sheet date.
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